The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures - A Single-blind, Randomized, Controlled Non-inferiority Study

Not Applicable

Not yet recruiting

• Conditions: Rheumatological Injection; Pain Management; Respiratory Monitoring

• Registration Number: NCT07172984
• Lead Sponsor: Centre Hospitalier Metropole Savoie

Brief Summary

The goal of this clinical trial is to demonstrate the non-inferiority of standardized breathing control exercises on perceived pain during rheumatological injections procedures compared to standard care consisting of the addition of a local anesthetic. The study population will consist of patients scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection. The main question it aims to answer is:

* Non-inferiority of breathing exercises compared to the addition of local anesthetic on pain and anxiety experienced during an infiltration procedure.

* Correlation between the reduction in pain and anxiety experienced during a procedure and the cardiac coherence score obtained.

Researchers will compare the anesthesia group (Arm A), which will receive local anesthesia with 5 cc of lidocaine before the infiltration procedure to the breathing group (Arm B), which will receive instructions before the injection procedure on how to perform 5-minute breathing cycles to facilitate the achievement of cardiac coherence to see if the pain perceived in Arm B is not greater than the pain perceived in Arm A.

Participants will be kept blind to their randomization group. Arm A (anesthesia) will receive SHAM breathing exercises, while Arm B (breathing) will receive a placebo injection of anesthetic.

Detailed Description

This randomized, controlled, single-blind, single-center non-inferiority study aims to evaluate the impact of local anesthesia and breathing exercises on pain and anxiety management during joint or periarticular injections. Participants are patients referred to a rheumatology consultation or referred by an outside physician for injections requiring local anesthesia, such as those performed on the shoulder, elbow, knee, hip, or ankle.

Patients will be kept blind to their randomization group. In both groups, continuous heart rate recording will be performed during the procedure using the EmWave PRO device (to assess cardiorespiratory variability and calculate a cardiac coherence score).

In the "anesthesia" group, local anesthesia with 5 cc of lidocaine will be administered before the infiltration procedure, and the patient will receive breathing instructions as part of "SHAM" management, which will prevent them from achieving cardiac coherence.

In the "breathing" group, patients will perform 5-minute breathing exercises before the procedure (10-second cycles: 5 seconds of inhalation and 5 seconds of exhalation) to enable them to achieve the expected analgesic cardiac coherence. The practitioner performing the procedure will use 5 cc of saline solution instead of the usual anesthesia.

After infiltration, participants' pain, anxiety, and satisfaction will be measured using EVA scale.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Study Start: 2025-09-20
• Primary Completion: 2028-09-20
• Study Completion: 2028-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Patient scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection.
• Patient able to sign an informed consent form to participate in the study

Exclusion Criteria

• Patient able to sign an informed consent form to participate in the study - - Allergy to the injection product or anesthetic.
• Injection not allowing the use of a local anesthetic due to insufficient joint volume (e.g., fingers/toes).
• Epidural injection via the sacrococcygeal hiatus.
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain during rheumatological injection	during injection	Pain perceived during rheumatological injection measured using a visual analog scale and compared between groups.

Secondary Outcome Measures

Name	Time	Method
pain correlated with cardiac coherence score	end of intervention	Pain measured using EVA scale, correlated within the experimental group with the cardiac coherence score.
anxiety during procedure	during the procedure	Anxiety experienced during the procedure, measured by EVA and compared between groups.
Cardiac coherence score	during procedure	Cardiac coherence score during injection (0 to 100, provided by the EMWAVE device) compared between the breathing group and the anesthesia group.

Trial Locations

Locations (1)

Centre Hospitalier Métropole Savoie; 🇫🇷 Chambéry, France